SOPHIA ANTIPOLIS, France, Nov. 12 /PRNewswire-FirstCall/ -- NicOx S.A.
(Eurolist: COX) today announced that results from the first pivotal phase 3
trial for naproxcinod in patients with osteoarthritis of the knee (the 301
study) were presented on November 10, 2007 at the 71st annual meeting of
the American College of Rheumatology (ACR), in Boston, Massachusetts (see
NOTE). Naproxcinod is NicOx' lead investigational drug product and the
first compound in the COX-Inhibiting Nitric Oxide Donator (CINOD) class.
The presentation contained additional efficacy data to the top-line results
announced in 2006 (see press release of October 27, 2006) which showed that
naproxcinod met all three co-primary endpoints of the trial. The data
showed that both doses of naproxcinod (750 mg and 375 mg bid) had superior
efficacy to placebo at all time points (2, 6 and 13 weeks). This
presentation also contained additional safety and tolerability information,
including the gastro-intestinal adverse event rates and blood pressure
measurements reported for each of the treatment groups.

Detailed clinical data from the 301 study were presented, including
data for each of the three co-primary efficacy endpoints: WOMAC(TM) pain
subscale, WOMAC(TM) function subscale and patients' overall rating of
disease status. Each of the active treatments (naproxcinod 750 mg,
naproxcinod 375 mg and naproxen 500 mg bid) were statistically
significantly superior to placebo (p<=0.0002) at 2, 6 and 13 weeks. In
addition, standard quality of life scores showed a functional improvement
for both naproxcinod doses, as well as for the naproxen group.

At week 13, both doses of naproxcinod (750 mg and 375 mg bid) showed a
slight decrease in systolic blood pressure in terms of the mean change from
baseline compared to placebo (0.8 and 0.2 mmHg, respectively), while a 2
mmHg increase was observed for naproxen compared to placebo. Patients'
blood pressure was measured by a health care professional using office
blood pressure measurements (OBPM) with standard equipment (i.e. a mercury
sphygmomanometer or aneroid device) during each study visit.

Both doses of naproxcinod were shown to be safe and well tolerated,
with 46.7% and 40.8% of patients experiencing at least one adverse event at
750 mg and 375 mg bid, respectively. In the naproxen and placebo bid
groups, 56.4% and 38.7% of patients experienced at least one adverse event,
respectively. In terms of gastro-intestinal adverse events, the naproxcinod
750 mg and 375 mg bid treatment groups reported event rates of 17.0% and
12.9%, respectively and the naproxen and placebo bid groups reported event
rates of 23.6% and 12.2%, respectively. The number of serious adverse
events was low and evenly spread among the treatment groups.

"I am very pleased to be presenting these phase 3 data for naproxcinod
at the ACR meeting, which is considered to be one of the leading events for
the scientific and medical community in rheumatology," declared Thomas J.
Schnitzer, MD, PhD, Professor of Medicine at Northwestern University
Feinberg School of Medicine, Principal Investigator on the 301 study.
"Naproxcinod exerts its therapeutic effect through the well-described
inhibition of the cyclo-oxygenase system and a sustained donation of nitric
oxide. In this clinical setting, nitric oxide may exert a protective effect
in the gastro-intestinal tract and play a homeostatic role in blood
pressure control. These phase 3 results suggest that naproxcinod may offer
a promising clinical and pharmacological profile for the treatment of the
signs and symptoms of osteoarthritis. These findings will need to be
confirmed by the ongoing 302 and 303 studies."

Details of the 301 study design and patient characteristics

A total of 918 patients were randomized at 120 clinical sites in the
United States to receive either naproxcinod 375 mg bid, naproxcinod 750 mg
bid, naproxen 500 mg bid or placebo bid for 13 weeks. Eligible patients
were at least 40 years old, with a clinical diagnosis of primary
osteoarthritis of the knee of at least 3 months duration, confirmed by
radiographs, and diagnosed according to the ACR guidelines (patients must
qualify as ACR global functional status I, II or III). Eligible patients
were also current users of Non-Steroidal Anti-inflammatory Drugs (NSAIDs)
or acetaminophen (paracetamol) for their osteoarthritis pain and these
analgesics were withdrawn before treatment with study-drug. The study
enrolled both hypertensive and non-hypertensive patients (50.3% of enrolled
patients were hypertensive at baseline). There were no statistically
significant differences among the four treatment groups for any baseline
variables, including hypertension medical history.

About naproxcinod

Naproxcinod is in phase 3 clinical development for the treatment of the
signs and symptoms of osteoarthritis. Two remaining pivotal phase 3 trials
for naproxcinod (the 302 and 303 studies) are currently ongoing and
efficacy results are expected to be reported in mid-2008. The Company will
conduct a statistical analysis according to a predefined plan on the pooled
OBPM data from the three phase 3 studies (301, 302 and 303), following the
completion of the 302 and 303 studies. NicOx anticipates filing a New Drug
Application for naproxcinod in the United States during the first quarter
of 2009.

NOTE: Within the framework of the ACR annual meeting held in Boston
from November 6 to 11, 2007, NicOx had a corporate booth to introduce the
Company and its technology to the scientific and medical community in the
United States.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of nitric oxide-
donating drugs to meet unmet medical needs. NicOx is targeting the
therapeutic areas of inflammation and cardio-metabolic disease. Resources
are focused on two lead compounds, naproxcinod (formerly HCT 3012), in
phase 3 development for the treatment of signs and symptoms of
osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.

NicOx has strategic partnerships with some of the world's leading
pharmaceutical companies, including Pfizer Inc. and Merck & Co., Inc.

NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a
public company listed on the Eurolist of Euronext(TM) Paris (segment: Next
Economy).

The elements included in this communication may contain forward-looking
statements subject to certain risks and uncertainties document of
reference. Actual results of the company may differ materially from those
indicated in the forward-looking statements because of different risks
factors described in the company's documents of reference.

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